MAUDE Adverse Event Report: POSEY PRODUCTS LLC CONNECTED ANKLE TWICE-AS-TOUGH CUFFS; RESTRAINT, PROTECTIVE

Model Number 2797

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Customer confirmed the product will not be returning for analysis.Therefore, this event is reported based on the information provided by the customer and from historical data of similar complaint.Sample and complaint recreation confirmed the reported issue.As such, ongoing investigation is underway to determine the root cause.Manufacturing reference file #(b)(4).Product will not be returning.

Event Description

Customer reported an event where the strap slipped through the d-ring attachment.The patient was still restrained within the cuffs but was allowed enough free mobility on the bed.Customer also reported that staff was nearby and was able to re-restrain the patient but that it took a longer duration.The date the issue was discovered is unknown and no patient incident or injury was reported.

Event Description

Supplemental needed for additional information.

Manufacturer Narrative

Voluntary corrective action recall is being performed to prevent a possible hazard to patients and caregivers, as the patients may self-release from restraints.Upon investigation, it was discovered that the twice-as-tough cuffs exhibit inadequate pull-strength that may allow for the strap to slip through the d-rings.This slippage may result in loosening of the patient¿s wrist(s) and/or ankle(s), providing a potential safety risk to the patient or the caregiver.The product is being replaced with product which meets the required pull-strength.A corrective and preventive action has been initiated.Manufacturer reference file #2019-00264 and r-00374.

• Brand Name: CONNECTED ANKLE TWICE-AS-TOUGH CUFFS
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck rd; arcadia CA 91006
• MDR Report Key: 8410961
• MDR Text Key: 138531894
• Report Number: 2020362-2019-00038
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• PMA/PMN Number: K963413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2797
• Device Catalogue Number: 2797
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1